search
Back to results

HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)

Primary Purpose

Unhealthy Lifestyle of Persons With Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Psycho educational and behavioural group sessions
Walking session
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Unhealthy Lifestyle of Persons With Mental Disorders focused on measuring lifestyle, mental disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • living in sheltered housing
  • diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)

Sites / Locations

  • Beschut Wonen Antwerpen
  • Beschut Wonen Min
  • Beschut Wonen Beernem
  • Beschut Wonen De Raster
  • Beschut Wonen Oostkust
  • Beschut Wonen Brugge
  • Beschut Wonen De Linde
  • Beschut Wonen De Wende
  • Beschut Wonen Centrum Onderweg
  • Beschut Wonen Delta Wonen
  • Beschut Wonen Domos
  • Beschut Wonen Zagan
  • Beschut Wonen Basis
  • Beschut Wonen West-Limburg
  • Beschut Wonen regio Izegem
  • Beschut Wonen De Bolster
  • Beschut Wonen De Hulster
  • Beschut Wonen Het Veer
  • Beschut Wonen Eigen Woonst
  • Beschut Wonen Oostende
  • Beschut Wonen Noord-Limburg
  • Beschut Wonen Roeselare-Tielt
  • Beschut Wonen Pro Mente
  • Beschut Wonen Waasland
  • Beschut Wonen Veurne-Diksmuide

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

health promotion program

Control group

Arm Description

Psycho education and behavioural group sessions and supervised walking sessions will be performed.

No intervention will be performed in this control group.

Outcomes

Primary Outcome Measures

change in body weight 10 weeks post-intervention
The primary outcome of the study consists of changes in body weight between baseline and 10-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
change in body weight 26 weeks post-intervention
The primary outcome of the study consists of changes in body weight between baseline and 26-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.

Secondary Outcome Measures

Body Mass Index 10 weeks post-intervention
Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²)
Body Mass Index, 26 weeks post-intervention
Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²).
Waist circumference, 10 weeks post-intervention
Waist circumference, assessed by using a tape measure.
Waist circumference, 26 weeks post-intervention
Waist circumference, assessed by using a tape measure.
Quality of Life, 10 weeks post-intervention
Quality of life, assessed by using the SF-36 Health Survey.
Quality of Life, 26 weeks post-intervention
Quality of life, assessed by using the SF-36 Health Survey.
Levels of physical activity, 10 weeks post-intervention
Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
Levels of physical activity, 26 weeks post-intervention
Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
Eating habits, 10 weeks post-intervention
Eating habits, assessed by using a 24-hour dietary recall.
Eating habits, 26 weeks post-intervention
Eating habits, assessed by using a 24-hour dietary recall.
Psychiatric symptom severity, 10 weeks post-intervention
Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
Psychiatric symptom severity, 26 weeks post-intervention
Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).

Full Information

First Posted
April 14, 2011
Last Updated
December 4, 2014
Sponsor
University Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT01336946
Brief Title
HEalth Promotion Intervention in MEntal Health Care
Acronym
HEPIMEC
Official Title
Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Overweight and obesity have become a serious global public health problem and the prevalence of these conditions is even higher among persons with mental disorders, compared with the general population. Overweight and obesity are partially associated with sedentary lifestyles and unhealthy eating habits. The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and eating habits in persons with mental disorders. The study hypothesis is that between baseline and the end of the intervention, and after a 6-month follow up period, significant differences in the primary and secondary outcomes between the intervention and control group will be identified. The investigators also hypothesize that the health promotion intervention will be cost-effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unhealthy Lifestyle of Persons With Mental Disorders
Keywords
lifestyle, mental disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
742 (Actual)

8. Arms, Groups, and Interventions

Arm Title
health promotion program
Arm Type
Experimental
Arm Description
Psycho education and behavioural group sessions and supervised walking sessions will be performed.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be performed in this control group.
Intervention Type
Behavioral
Intervention Name(s)
Psycho educational and behavioural group sessions
Intervention Description
10 psycho educational and behavioural group sessions on topics like the Food Triangle, healthy eating, the importance of physical activity, healthy eating on a limited budget, implementing physical activity into the daily life, the influence of advertisements...
Intervention Type
Behavioral
Intervention Name(s)
Walking session
Intervention Description
A weekly supervised walking session (30 minutes) in a 10-week period.
Primary Outcome Measure Information:
Title
change in body weight 10 weeks post-intervention
Description
The primary outcome of the study consists of changes in body weight between baseline and 10-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
Time Frame
after 10 weeks
Title
change in body weight 26 weeks post-intervention
Description
The primary outcome of the study consists of changes in body weight between baseline and 26-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
Time Frame
after 26 weeks
Secondary Outcome Measure Information:
Title
Body Mass Index 10 weeks post-intervention
Description
Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²)
Time Frame
after 10 weeks
Title
Body Mass Index, 26 weeks post-intervention
Description
Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²).
Time Frame
after 26 weeks
Title
Waist circumference, 10 weeks post-intervention
Description
Waist circumference, assessed by using a tape measure.
Time Frame
After 10 weeks
Title
Waist circumference, 26 weeks post-intervention
Description
Waist circumference, assessed by using a tape measure.
Time Frame
After 26 weeks
Title
Quality of Life, 10 weeks post-intervention
Description
Quality of life, assessed by using the SF-36 Health Survey.
Time Frame
After 10 weeks
Title
Quality of Life, 26 weeks post-intervention
Description
Quality of life, assessed by using the SF-36 Health Survey.
Time Frame
After 26 weeks
Title
Levels of physical activity, 10 weeks post-intervention
Description
Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
Time Frame
After 10 weeks
Title
Levels of physical activity, 26 weeks post-intervention
Description
Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
Time Frame
After 26 weeks
Title
Eating habits, 10 weeks post-intervention
Description
Eating habits, assessed by using a 24-hour dietary recall.
Time Frame
After 10 weeks
Title
Eating habits, 26 weeks post-intervention
Description
Eating habits, assessed by using a 24-hour dietary recall.
Time Frame
After 26 weeks
Title
Psychiatric symptom severity, 10 weeks post-intervention
Description
Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
Time Frame
After 10 weeks
Title
Psychiatric symptom severity, 26 weeks post-intervention
Description
Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
Time Frame
After 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older living in sheltered housing diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven Annemans, Ph.D., Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beschut Wonen Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
Beschut Wonen Min
City
Antwerpen
Country
Belgium
Facility Name
Beschut Wonen Beernem
City
Beernem
Country
Belgium
Facility Name
Beschut Wonen De Raster
City
Beigem
Country
Belgium
Facility Name
Beschut Wonen Oostkust
City
Blankenberge
Country
Belgium
Facility Name
Beschut Wonen Brugge
City
Brugge
Country
Belgium
Facility Name
Beschut Wonen De Linde
City
Diest
Country
Belgium
Facility Name
Beschut Wonen De Wende
City
Eeklo
Country
Belgium
Facility Name
Beschut Wonen Centrum Onderweg
City
Gent
Country
Belgium
Facility Name
Beschut Wonen Delta Wonen
City
Gent
Country
Belgium
Facility Name
Beschut Wonen Domos
City
Gent
Country
Belgium
Facility Name
Beschut Wonen Zagan
City
Gent
Country
Belgium
Facility Name
Beschut Wonen Basis
City
Hasselt
Country
Belgium
Facility Name
Beschut Wonen West-Limburg
City
Heusden-Zolder
Country
Belgium
Facility Name
Beschut Wonen regio Izegem
City
Izegem
Country
Belgium
Facility Name
Beschut Wonen De Bolster
City
Kortrijk
Country
Belgium
Facility Name
Beschut Wonen De Hulster
City
Leuven
Country
Belgium
Facility Name
Beschut Wonen Het Veer
City
Maasmechelen
Country
Belgium
Facility Name
Beschut Wonen Eigen Woonst
City
Menen
Country
Belgium
Facility Name
Beschut Wonen Oostende
City
Oostende
Country
Belgium
Facility Name
Beschut Wonen Noord-Limburg
City
Overpelt
Country
Belgium
Facility Name
Beschut Wonen Roeselare-Tielt
City
Roeselare
Country
Belgium
Facility Name
Beschut Wonen Pro Mente
City
Sint-Niklaas
Country
Belgium
Facility Name
Beschut Wonen Waasland
City
Sint-Niklaas
Country
Belgium
Facility Name
Beschut Wonen Veurne-Diksmuide
City
Veurne
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
23855449
Citation
Verhaeghe N, Clays E, Vereecken C, De Maeseneer J, Maes L, Van Heeringen C, De Bacquer D, Annemans L. Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial. BMC Public Health. 2013 Jul 15;13:657. doi: 10.1186/1471-2458-13-657.
Results Reference
derived
PubMed Identifier
22694796
Citation
Verhaeghe N, De Maeseneer J, Maes L, Van Heeringen C, Bogaert V, Clays E, De Bacquer D, Annemans L. Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial. BMC Public Health. 2012 Jun 13;12:431. doi: 10.1186/1471-2458-12-431.
Results Reference
derived

Learn more about this trial

HEalth Promotion Intervention in MEntal Health Care

We'll reach out to this number within 24 hrs